FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780500087
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
29-33-24
Catalog number
29-33-24
Device description
"Integra® Miltex® Walther Female Dilator-Catheter, 5-1/2"", 24 French"
Published
2018-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBXSOUND, URETHRAL, METAL OR PLASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBXSound, Urethral, Metal Or PlasticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780500087PrimaryGS10
H8342933240SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178050008710381780500087

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral drainage catheter, non-antimicrobial, reusableA flexible or rigid tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass]; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge24French
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780191070Integra® Jarit®400293400-2932018-04-02
10381780193180Integra® Jarit®P408P4082018-04-02
10381780197997Integra® Jarit®380232380-2322017-09-29
10381780198000Integra® Jarit®380233380-2332018-03-22
10381780198543Integra® Jarit®385295385-2952018-03-22
10381780220121Integra® Jarit®P666P6662018-01-31
10381780390381Integra® Jarit®380230380-2302018-02-16
10381780390398Integra® Jarit®380231380-2312018-02-16
10381780456469Integra® Jarit®405225405-2252018-01-31
10381780457190Integra® Jarit®P667P6672018-01-31
10381780458159Integra® Jarit®385315385-3152018-03-01
10381780458166Integra® Jarit®385316385-3162018-03-01
10381780487708Integra® Miltex®MH21-300MH21-3002018-08-22
10381780503910Integra® Miltex®PM-666PM-6662020-10-01
10381780520665CereLink™82684582-68452020-04-01
10381780087984Integra®375001237500122018-10-26
10381780081371Integra®372201137220112018-10-24
10381780081388Integra®372201237220122018-10-24
10381780081906Integra®372206937220692018-10-24
10381780081913Integra®372207037220702018-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780509356Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-10-23
10381780500025Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500032Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500049Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500056Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500063Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500070Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500094Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500100Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500117Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500124Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500131Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500148Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500155Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500162Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500179Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500186Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500193Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500209Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500216Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500223Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500230Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500247Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500254Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500261Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500278Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500285Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500292Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500308Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500315Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18